Can the Memory Support Intervention Improve Depression Outcome Following Cognitive Therapy?
28. januar 2021 opdateret af: Allison Harvey, University of California, Berkeley
The aim of this study protocol is to conduct a confirmatory efficacy trial to test whether the Memory Support Intervention improves illness course and functional outcomes in major depressive disorder (MDD) and cognitive therapy (CT).
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Background. Major depressive disorder (MDD) is one of the most prevalent psychiatric disorders and a leading cause of disability worldwide. Existing therapies fail to produce complete recovery. Progress toward improving outcome must include innovations that are safe, powerful, inexpensive and simple (for fast and effective dissemination). The proposed research seeks to test one such innovation. The investigators seek to improve outcome by improving memory for the content of cognitive therapy (CT) sessions. CT is one of the most promising approaches to the treatment of MDD, yet there is room for improvement.
It is proposed that adding memory enhancing strategies to CT may improve MDD outcome because: (a) MDD is often characterized by memory impairment, (b) there is evidence that the memory impairment is modifiable, (c) CT typically entails the activation of emotion, (d) emotion can impair or bias memory and (e) there is evidence that memory for the content of therapy sessions is poor.
Hence, the overall goal is to evaluate if integrating strategies designed to enhance memory for the content of CT sessions improves treatment outcome for MDD. Cognitive support involves a series of specific procedures that support the encoding and retrieval stages of an episodic memory. It is hypothesized that CT+Memory Support, relative to CT-as-usual, will be associated with improved illness course and functional outcome at the end of treatment as well as 6 and 12 months post-treatment.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
178
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
Berkeley, California, Forenede Stater, 94720-1650
- University of California, Berkeley
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age 18+ years
- Willing and able to give full consent
- English language fluency
- Diagnosis of major depressive disorder (MDD), first episode, recurrent or chronic, according to DSM-5
- Minimum score 26 or above on the Inventory of Depressive Symptomatology, Self-Report (IDS-SR). This cutoff denotes at least 'moderate' depression
- If taking medications for mood, medications must be stable for the past four weeks
Exclusion Criteria:
- History of Bipolar Disorder
- History of Psychosis or psychotic features
- Lifetime history of failure to respond to 4 or more sessions of CBT/CT for depression
- Current non-psychotic disorder if it constitutes the principal diagnosis and if it requires treatment other than that offered in the project. 'Principal' is defined as the disorder currently most distressing and disabling, using a widely accepted severity rating scale capturing distress and interference (0-8, 4+ indicates clinical severity)
- Moderate or severe substance use in the past 6 months where 'moderate' is defined as 4-5 symptoms and 'severe' is defined as 6+ listed in DSM-5 for each of the substance-related disorders
- Evidence of any medical disorder or condition that could cause depression, preclude participation in CT, or is associated with memory problems, that is not currently stabilized and/or managed under the care of a physician or the presence of an active and progressive physical illness or neurological degenerative disease,
- Current suicide risk sufficient to preclude treatment on an outpatient basis (assessed by the Columbia-Suicide Severity Rating Scale) or current homicide risk (assessed by our staff, a case manager or psychiatrist)
- Pregnancy or breastfeeding
- Not able/willing to participate in and/or complete the pre-treatment assessments
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cognitive Therapy plus Memory Support
|
The Memory Support Intervention will be delivered interwoven with CT.
The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory.
It is comprised of eight memory promoting strategies: attention recruitment, categorization, evaluation, application, repetition, practice remembering, cued-based reminder and praise recall.
These strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding.
Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment.
|
|
Aktiv komparator: Cognitive Therapy-as-usual
|
There is evidence that CT for major depressive disorder (MDD) can be as effective as antidepressant medication for the initial treatment of moderate to severe MDD.
Moreover, following the withdrawal of treatment, patients treated with CT are significantly less likely to relapse than patients treated with antidepressant medication and CT is at least as effective as antidepressant medication in preventing subsequent relapse.
CT aims to alter the symptomatic expression of depression and reduce risk for subsequent episodes by correcting the negative beliefs and maladaptive information processing presumed to underlie the disorder and alter the systematic tendency to misperceive reality in a pessimistic fashion.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Remission
Tidsramme: Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
|
% Remission is defined as signs and symptoms must be absent or close to it for >=3 weeks and operationalized as IDS-SR less than 14.
|
Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
|
|
Relapse at 6 Months
Tidsramme: Calculated at 6-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
|
% Relapse is defined as 'return to an MDE following remission' and operationalized as greater than or equal to 14 on the IDS-SR at follow-up for those who had remitted.
|
Calculated at 6-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
|
|
Relapse at 12 Months
Tidsramme: Calculated at 12 months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
|
% Relapse is defined as 'return to an MDE following remission' and operationalized as greater than or equal to 14 on the IDS-SR at follow-up for those who had remitted.
|
Calculated at 12 months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
|
|
Functional Impairment
Tidsramme: Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
WHODAS 2.0 total score
|
Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
|
Patient Memory for Treatment
Tidsramme: Week 4, Week 8, Week 12, Week 16 of treatment as well as Post Treatment, defined as two post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
Cumulative Recall on the Patient Treatment Recall Task
|
Week 4, Week 8, Week 12, Week 16 of treatment as well as Post Treatment, defined as two post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
|
Generalization Task
Tidsramme: Week 4, Week 8, Week 12, and Week 16 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
Week 4, Week 8, Week 12, and Week 16 of treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
|
|
Declarative Memory
Tidsramme: Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
Hit Rate minus False Alarm Rate minus Lure Rate on the Episodic Face-Name Learning Task
|
Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
|
Working Memory
Tidsramme: Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
No. of correct hits minus the no. of false positives on 3-Back of the N-Back
|
Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
|
Memory Support
Tidsramme: 20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
|
Total Amount on the Memory Support Rating Scale on randomly selected therapy tapes.
|
20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Response to Treatment
Tidsramme: Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
|
% Response is defined as a clinically significant degree of symptom reduction and operationalized as 50% reduction in pre-treatment symptom severity on the IDS-SR.
|
Post-Treatment which is two weeks after final therapy session (i.e. 18-20 weeks after initial intake interview)
|
|
Magnitude of symptom change is operationalized as change on IDS-SR
Tidsramme: Change from Pretreatment to Post-Treatment
|
Change from Pretreatment to Post-Treatment
|
|
|
Recovery
Tidsramme: Calculated at 6-months and 12-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
|
% Recovery is defined as 'remission sustained for >=4 months' and is operationalized via the LIFE.
|
Calculated at 6-months and 12-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
|
|
Recurrence
Tidsramme: Calculated at 6-months and 12-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
|
% Recurrence is defined as 'return to an MDE following recovery' and is established using the SCID.
|
Calculated at 6-months and 12-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
|
|
Time to relapse or recurrence
Tidsramme: Calculated at 6-months and 12-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
|
Time to relapse or recurrence following response or remission will be established using the SCID.
|
Calculated at 6-months and 12-months after the end of treatment [the end of treatment is defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview
|
|
Functional Impairment
Tidsramme: Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
4-question Healthy Days core module
|
Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
|
Patient Memory for Treatment
Tidsramme: Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
Past Session Recall on the Patient Treatment Recall Task
|
Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
|
Working Memory
Tidsramme: Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
No. of correct hits minus the no. of false positives on 0-Back, 1-Back, 2-Back of the N-Back
|
Change from pre-treatment to post-treatment defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview) to 6-month follow-up to 12-month follow-up
|
|
Memory Support
Tidsramme: 20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
|
Number of Types on the Memory Support Rating Scale
|
20-26 sessions of treatment (over 16 weeks) spanning 18-20 weeks after initial intake interview
|
|
Competencies of Cognitive Therapy Scale (CCTS) (Exploratory)
Tidsramme: Post Treatment, defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview), 6 month Follow-Up, 12 month Follow-Up
|
Measure of patient competence at using cognitive therapy skills.
|
Post Treatment, defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview), 6 month Follow-Up, 12 month Follow-Up
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pre-Treatment Assessment Telephone Screen to determine Eligibility
Tidsramme: Pre-Treatment
|
Pre-Treatment
|
|
|
Structure Clinical Interview for DSM-5 (SCID)
Tidsramme: Pre-Treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview), 6 month Follow-Up, 12 month Follow-Up
|
Pre-Treatment as well as Post Treatment, defined as two weeks after the final therapy session (i.e. 18-20 weeks after the initial intake interview), 6 month Follow-Up, 12 month Follow-Up
|
|
|
Quick Inventory for Depressive Symptomatology-Self-Report (QIDS)
Tidsramme: At the beginning of every treatment session (i.e., for 18-20 weeks after the initial intake interview)
|
At the beginning of every treatment session (i.e., for 18-20 weeks after the initial intake interview)
|
|
|
IQ National Adult Reading Test (NART)
Tidsramme: Pre-Treatment
|
Pre-Treatment
|
|
|
Treatment Provider Recall Task
Tidsramme: Week 4, Week 8, Week 12, Week 16, and last session of treatment, defined as 16-18 weeks after the initial intake interview
|
Week 4, Week 8, Week 12, Week 16, and last session of treatment, defined as 16-18 weeks after the initial intake interview
|
|
|
Medication (medication type and dosage)
Tidsramme: Duration of Study which is at the pre-treatment assessment, at the post-treatment which defined as two weeks after the final therapy session (i.e., 18-20 weeks after the initial intake interview), at the 6-month follow-up and at the 12-month follow-up.
|
Duration of Study which is at the pre-treatment assessment, at the post-treatment which defined as two weeks after the final therapy session (i.e., 18-20 weeks after the initial intake interview), at the 6-month follow-up and at the 12-month follow-up.
|
|
|
Other Treatment/Therapy Tracking Log (presence/absence)
Tidsramme: Duration of Study which is at the pre-treatment assessment, at the post-treatment which defined as two weeks after the final therapy session (i.e., 18-20 weeks after the initial intake interview), at the 6-month follow-up and at the 12-month follow-up.
|
Duration of Study which is at the pre-treatment assessment, at the post-treatment which defined as two weeks after the final therapy session (i.e., 18-20 weeks after the initial intake interview), at the 6-month follow-up and at the 12-month follow-up.
|
|
|
Credibility/Expectancy Questionnaire (CEQ)
Tidsramme: Treatment Week 2 and 2 weeks Post-Treatment, at the 6-month follow-up and at the 12-month follow-up
|
Treatment Week 2 and 2 weeks Post-Treatment, at the 6-month follow-up and at the 12-month follow-up
|
|
|
Patient usefulness and utilization of cognitive therapy skills scale (Exploratory)
Tidsramme: 2 weeks post-treatment, 6-post-treatment, 6-month follow-up, and 12-month follow-up
|
Measure completed by patients indicating how useful they found specific cognitive therapy skills, and how often they used each skill.
|
2 weeks post-treatment, 6-post-treatment, 6-month follow-up, and 12-month follow-up
|
|
Patient Conceptualization of Depression Task (Exploratory)
Tidsramme: pre-treatment, post-treatment, 6-month follow-up
|
pre-treatment, post-treatment, 6-month follow-up
|
|
|
Treatment Adherence Rating Scale-Therapist Version
Tidsramme: After each treatment session filled out by therapist (20-26 times)
|
After each treatment session filled out by therapist (20-26 times)
|
|
|
Memory Support Treatment Provider Checklist
Tidsramme: After treatment sessions in weeks 4, 8, 12, and 16 filled out by therapist (4 times)
|
After treatment sessions in weeks 4, 8, 12, and 16 filled out by therapist (4 times)
|
|
|
Memory Support Rating Scale
Tidsramme: Week 1, Week 4, Week 8, Week 12, Week 16 of treatment
|
Week 1, Week 4, Week 8, Week 12, Week 16 of treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2016
Primær færdiggørelse (Faktiske)
5. august 2020
Studieafslutning (Faktiske)
5. august 2020
Datoer for studieregistrering
Først indsendt
6. oktober 2016
Først indsendt, der opfyldte QC-kriterier
17. oktober 2016
Først opslået (Skøn)
19. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. januar 2021
Sidst verificeret
1. januar 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01MH108657 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .